产品合规专员

该职位来源于猎聘 RESPONSIBILITIES 岗位职责：

• Ensure compliance with market-specific applications in sensitive end-use applications such as personal care, food contacting, pharma, medical device, etc.

确保产品在个人护理、食品接触、制药和医疗器械等敏感终端应用中符合特定市场的法规要求。

• Conduct regulatory assessment and develop registration strategy, plan and dossier preparation in support of new product initiatives and product line extensions for market specific applications in Asia Pacific.

开展法规评估，制定注册策略与计划，并准备注册申报资料，以支持亚太地区面向特定市场应用的新产品项目及产品线扩展。

• Help drive regulatory and compliance as part of commercial strategy for existing or new product launches.

将法规与合规要求纳入现有产品或新产品上市的商业策略，并推动相关工作落实。

• Provide internal and external customer regulatory trainings and daily regulatory supports to demonstrate our competence.

为内部及外部客户提供法规培训和日常法规支持，展现公司的专业能力。

• Monitor related regulations developments in Asia Pacific and conduct advocacy as needed through active participation in trade associations/industry groups and through direct interaction with regulators in Asia Pacific.

跟踪亚太地区相关法规的发展动态，并根据需要通过积极参与行业协会与行业组织，以及与亚太地区监管机构直接沟通，开展法规倡导工作。 REQUIREMENTS岗位要求：

• Bachelor’s degree or above in Chemistry, Polymer, Toxicology, Pharmacy, Medical, or other related majors. 化学、聚合物、毒理学、药学、医学或其他相关专业本科及以上学历。
• At least 5+ years’ experience in product stewardship or product regulatory compliance experience in industry new chemical substance, cosmetic safety risk assessment, food contacting registration, China new cosmetic registration, China pharma excipient filing, China medical device related product registration dossier submission and working with regulators. 至少5年产品管理（Product Stewardship）或产品法规合规经验，并具备以下一个或多个领域的行业经验：新化学物质、化妆品安全风险评估、食品接触材料注册、中国化妆品新原料注册、中国药用辅料备案、中国医疗器械相关产品注册资料提交，以及与监管机构沟通。
• Excellent oral / written communication and interpersonal skills (Fluency in English is a must). 具备出色的口头、书面沟通及人际交往能力；必须具备流利的英语能力。